Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

This study has been terminated.

(The study was stopped because of slow accrual)

Sponsor:

CureTech Ltd

ClinicalTrials.gov Identifier:

NCT00966251

First Posted: August 26, 2009

Last Update Posted: October 23, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Not eligible for any other systemic anti-neoplastic treatment approved for HCC

Not eligible for Transarterial chemoembolization (TACE ).

No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.

Not a candidate for curative surgical resection or liver transplantation

Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.

Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)

Child's Pugh classification A

ECOG performance status 0-1

Exclusion Criteria:

Patients progressing to liver failure.

No core biopsy within the past 7 days

Patients who are eligible for Transarterial Chemoembolization (TACE)

Patients on concurrent anti-neoplastic therapy (including interferon)

Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.

Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids

Presence of metastasis.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966251